Clinical trial · Interventional
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colonic Adenoma | Colon Adenoma | ALIAS | 0.90 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CADe colonoscopy using GI Genius device | Device | — | UNRESOLVED |
| White light | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Artificial intelligence arm Patients undergoing colonoscopy with artificial intelligence.
- description
- Patients undergoing colonoscopy with artificial intelligence.
- interventionNames
- Device: CADe colonoscopy using GI Genius device
- type
- ACTIVE_COMPARATOR
- label
- Conventional Colonoscopy
- description
- Standard Colonoscopy with white light
- interventionNames
- Device: White light
Primary outcomes (2)
- measure
- Adenoma detection rate
- timeFrame
- When available the histological report of polyps removed (up to 3 weeks).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program. Exclusion Criteria: * Patients unwilling or unable to give informed consent. * Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.
References
Publications (0)
Data not yet available